Mirror, Ent
An ENT mirror is a small, angled reflective instrument used by clinicians to visualize areas of the ear, nose, and throat that are otherwise inaccessible to direct inspection, such as the nasopharynx, larynx, or inner ear canal. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls without any premarket clearance requirement. Product code KAI is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KAI
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K833601 | ANTRUM & ATTIC MIRROR | Jan 03, 1984 | Substantially Equivalent | Microtek Medical, Inc. |
| K823915 | MIRROR TIP | Jan 21, 1983 | Substantially Equivalent | Treace Medical, Inc. |
| K822374 | BUCKINGHAM ATTIC & ANTRUM MIRROR | Sep 09, 1982 | Substantially Equivalent | Treace Medical, Inc. |
| K822261 | LARYNGEAL MIRRORS | Aug 30, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822191 | HEAD MIRROR WITH HEADBAND | Aug 20, 1982 | Substantially Equivalent | Kelleher Corp. |
| K820354 | ATMOS MIRROR WARMER | Mar 01, 1982 | Substantially Equivalent | Jedmed Instrument Co. |
| K781750 | MIRROR WARMER | Jan 17, 1979 | Substantially Equivalent | Arleton Technical Products, Inc. |
| K770054 | MIRROR, NASO-PHARYNX | Jan 18, 1977 | Substantially Equivalent | Welch Allyn, Inc. |
| K770053 | MIRROR, LARYNGEAL | Jan 18, 1977 | Substantially Equivalent | Welch Allyn, Inc. |
FEI Numbers
This FDA classification entry is associated with 108 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 108 registration numbers. Click on an entry to view related FDA registrations.